Investigating the Effect of Interval Walking and Qigong on People With Knee Osteoarthritis: Pilot Study
1 other identifier
interventional
45
1 country
1
Brief Summary
Knee osteoarthritis (KOA) causes pain and limited function that leads to a sedentary lifestyle. The sedentary lifestyle increases the risk of cardiovascular diseases. In addition, many subjects with KOA have knee pain and sleep disturbance that limit their function, quality of life and cause body fatigue. Walking exercise can benefit people with KOA. However, continues walking for more than 30 minutes can increase pain that may stop people from participation in walking exercise. Interval walking may complete the same amount of walking exercise in several separate time periods, without causing extra pain in people with KOA. Mind-body exercise may improve sleep and pain in people with KOA. This study will help researchers to find out whether the interval walking, or mind-body exercise may help people with KOA to improve their pain, fitness level, sleep quality, exercise participation, fatigue, and quality of life. By doing this study, researchers hope to learn more about the interval walking or mind-body exercise in people with KOA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
October 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 26, 2022
May 1, 2022
1.8 years
August 11, 2020
May 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Feasibility measurement: recruitment, compliance, and dropout
Feasibility will be quantified using rates of participant recruitment, compliance, and dropout rate from the exercise program using exercise diary filled by the exercise supervisor. The Percentage of recruited subjects per month will be reported. The dropout rate is defined as the percentage of subjects who do not complete the study intervention and choose to withdraw. The compliance is defined as the percentage of the completed exercise program. The exercise diary log of subjects who drop out of the study will not be included when compliance is calculated. (feasibility measures will be reported in percentage)
6 week
Acceptability
Acceptability will be assessed via participants' program evaluation scores and rating of treatment satisfaction at the end-intervention evaluation. The subjects will be asked to score, on an 11-point scale, ranging from 0 (poor) to 10 (excellent) for questions "How do you rate this exercise program overall in regarding to ease of use?" and "How do you rate this exercise program overall in regarding to improving your symptoms?" Participants will be also asked to rate their overall level of satisfaction with the intervention using an 11-point numerical rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
6 week
Secondary Outcomes (13)
Comprehensive pain assessment: the Measure of Intermittent and Constant Osteoarthritis Pain
6 week
Resting heart rate (rHR) and heart rate recovery (HRR)
6 week
Heart rate variability (HRV)
6 week
Blood pressure
6 week
insomnia severity
6 week
- +8 more secondary outcomes
Study Arms (3)
interval group
EXPERIMENTALQigong exercise
EXPERIMENTALcontinuous walking
ACTIVE COMPARATORInterventions
Interval walking: The subjects will be asked to complete daily 30 minutes of walking in two 15-minute bouts with the rest interval for at least 0.5 an hour and not more than 2 hours between each bout. Qigong exercise: mind-body exercise using the "six healing sound" Qigong exercise will be used because it is easy to learn, requires minimal physical capability, and can be performed even in a sitting body position.
Eligibility Criteria
You may qualify if:
- years of age and diagnosed with KOA by a physician or meet the ACR criteria (95% sensitivity, and 69% specificity) for KOA. The ACR criteria include experiencing almost daily knee pain and having at least 3 of these 6 criteria: (1) Age more than 50 years old, (2) less than 30 minutes of morning stiffness, (3) increased warmth of the knee, (4) crepitus with flexion or extension, (5) joints' bony enlargement , and (6) tenderness of joint line with palpation, or subject must be diagnosed radiologically, with grade II or more according to the Kellgren and Lawrence rating scale.
- Frequent knee pain or aching on most of the preceding 30 days.
- An average of mild to moderate pain intensity level (5 to 75 mm on the 100 mm VAS) in the last 7 days
- Sedentary lifestyle assessed using 2011 Compendium of Physical Activities questionnaire. The subject is considered sedentary if engaging in exercise or physical activity with metabolic equivalents of task (MET) less than 4, not more than two times/week.
You may not qualify if:
- Unwilling to attend 3 sessions/week at Kirmayer Fitness Center
- Having other types of arthritis such as rheumatoid arthritis or gout
- Neurological disorders
- CVD including hypertension that prevent them from engaging in walking exercise
- Currently using beta blocker medication
- Underwent any lower limb surgery during the past 6 months
- A history of two or more incidents of fall during the last 6 months
- Current hip or spine pain that prevents them from engaging in walking exercise.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wen Liu
Kansas City, Kansas, 66103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 27, 2020
Study Start
October 13, 2020
Primary Completion
August 1, 2022
Study Completion
October 1, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share